Prosthesis comprising a core of a gel material with a woven envelope and a method for producing the same and use thereof

Abstract

The present application relates to a prosthesis comprising a core of a gel material and a fiber envelope which surrounds the core. In addition, the present application relates to a method for producing the same. The object of the present application is to provide a prosthesis which is based on a material which combines a low shear stiffness with a high degree of toughness and good swelling properties. Another object of the present invention is to provide a prosthesis which is based on a material which exhibits excellent durability and wear resistance.

The invention claimed is: 
     
       1. A prosthesis comprising a core of a gel material and a fibre envelope which surrounds the core, wherein the fibre envelope consists of a woven material and comprises at least two layers of the woven material which are connected to one another and surround the core. 
     
     
       2. A prosthesis of  claim 1 , wherein the fibre envelope comprises traction-resistant fibres. 
     
     
       3. A prosthesis of  claim 2 , wherein the traction-resistant fibres have a tensile strength of at least 1 Gpa. 
     
     
       4. A prosthesis of  claim 1 , wherein the envelope comprises at least two or more layers of woven material. 
     
     
       5. The prosthesis of  claim 1 , wherein the envelope is knitted or knotted. 
     
     
       6. The prosthesis of  claim 1 , wherein the envelope has a mesh size of at most 1 mm 2 . 
     
     
       7. The prosthesis of  claim 5 , wherein the envelope is knitted and has a stitch density of at least 10 stitches per inch (4 stitches per cm). 
     
     
       8. The prosthesis of  claim 1 , wherein the fibre envelope comprises polyethylene fibres. 
     
     
       9. The prosthesis of  claim 1 , wherein the gel material is a hydrogel. 
     
     
       10. The prosthesis of  claim 9 , wherein the hydrogel is reinforced with fibres having a tensile strength of at most 1 GPa. 
     
     
       11. The prosthesis of  claim 9 , wherein the hydrogel is reinforced with an amount of fibres of at least 5%, based on the weight of the hydrogel. 
     
     
       12. The prosthesis of  claim 10 , further comprising a protective layer present between the core and the envelope, which protective layer envelopes the core entirely or partial. 
     
     
       13. The prosthesis of  claim 12 , wherein the protective layer has pores having a pore size ranging between 1 nm and 100 μm. 
     
     
       14. The prosthesis of  claim 1 , wherein the stiffness of the prosthesis depends on the swelling pressure in the prosthesis, which is obtained by the balance between the swelling of the gel and the stiffness of the woven envelope, so that the fibres are biased and the amount of swelling is restricted. 
     
     
       15. A method for manufacturing the prosthesis of  claim 1 , wherein a core consisting of a gel material is provided with an envelope, wherein a woven envelope is provided. 
     
     
       16. The method of  claim 15 , wherein the woven envelope is produced separately from the core, after which the core is transferred thereto. 
     
     
       17. The method of  claim 15 , wherein the woven envelope is arranged around the core in situ. 
     
     
       18. The method of  16 , wherein hydrogel is used as the gel material, which hydrogel is preferably placed in the envelope in a completely or partially dehydrated state. 
     
     
       19. A method for replacing an entire intervertebral disc, a nucleus of an intervertebral disc or a meniscus with a prosthesis comprising a core of a gel material and a fibre envelope which surrounds the core, wherein the fibre envelope consists of a woven material and comprises at least two layers of the woven material which are connected to one another.